VACCINE

濱田 福三郎 NAF01626 at NIFTYSERVE.OR.JP
Tue Feb 21 04:44:55 EST 1995


TO:INET:virology at net.bio.net
FROM:NAF01626 at niftyserve.or.jp
SUB:Live flu vaccine

Cold adapted live flu vaccine is probably the best vaccine. However,
when think of regulatory issue, it would be controvercial.  Because of
nature of influenza virus, antigenic shift or drift, we have to generate
new reassortants almost every year.  Under the conditions, clinical 
study should be done for all new vaccine strains to know the efficacy 
and safety.  However, limited time do not allow us to do so.  Practically,
one has to apply NDA with a certain amount of clinical data.  What is
the most elegant design to show the efficacy and safety of vaccine 
strains used in a clinical study and to guarantee the property of vaccines 
coming in the future?

I would appreciate any comments .



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